CDSCO REGISTRATION
The Central Drugs Standard Control Organisation (CDSCO) is the National Regulatory Authority for Indian pharmaceuticals and medical devices under the Directorate General of Health Services, Ministry of Health and Family Welfare in India. It is the responsibility of CDSCO for approving new drugs and conduct of clinical trials in India under the Drugs and Cosmetics Act, 1940 (“Act”) and Drugs and Cosmetics Rules, 1945 (“Rules”). It also lays down standards for drugs and controls the quality of imported drugs and cosmetics in the country for bringing about uniformity in the enforcement of the Act and Rules.
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The Central Drugs Standard Control Organisation (CDSCO) is the National Regulatory Authority for Indian pharmaceuticals and medical devices under the Directorate General of Health Services, Ministry of Health and Family Welfare in India. It is the responsibility of CDSCO for approving new drugs and conduct of clinical trials in India under the Drugs and Cosmetics Act, 1940 (“Act”) and Drugs and Cosmetics Rules, 1945 (“Rules”). It also lays down standards for drugs and controls the quality of imported drugs and cosmetics in the country for bringing about uniformity in the enforcement of the Act and Rules.
In 2010, the Government of India issued a gazetted notification regarding importing foreign cosmetic products. In that, it made it mandatory to obtain a CDSCO import license for those who wish to import and sell cosmetic products across India.
Any organisation that imports or manufacturers or exports drugs and cosmetics, conducts R & D activities concerning drugs, imports drugs for the purpose of testing, conducts Bioavailability (BA) and Bioequivalence (BE) studies in drugs for export purposes need to obtain registration under the CDSCO through its registration portal.
PURPOSE FOR CDSCO REGISTRATION
CDSCO can grant registration for different purposes. The different purposes for which an applicant can register under the CDSCO portal are:
- Cosmetics Registration
- Import or Manufacture of drugs
- Export NOC (Zone)
- Test License
- Ethics Committee Registration
- Formulation R&D Organisation
- Blood Bank Registration
- Blood Product Registration
- Dual Use NOC (Trader)
- BA/BE Approved Sites
- Sponsors (BA/BE and CT)
ELIGIBILITY FOR CDSCO REGISTRATION
As per CDSCO guidelines, the following are the parties eligible to get cosmetic license registration for import or CDSCO registration certificate:
- A manufacturer company with a registered operating office in the country(India).
- Any authorized agent of the said manufacturer.
- A subsidiary company of that manufacturer.
- Any other import who wishes to deal with the business of importing cosmetic products from other countries.
BENEFITS OF CDSCO REGISTRATION
The manufacturer or importer of drugs can benefit greatly from a CDSCO Drugs Import License. The intended population is protected, and the seller is free from any legal repercussions when they sell drugs in India. Some of the benefits of a CDSCO drugs import license are-
- It ensures patients’ safety and makes sure that they are not exposed to health risks.
- When CDSCO certifies a drug, it undergoes quality assurance testing at a certified lab, has a quality certificate and produces the best outcomes possible for the patients.
- The regulatory body ensures that the imported drug is of good quality. This is the rationale behind establishment of the regulatory body to address products of average and subpar quality.
- CDSCO Drugs Import License strengthens the brand identity of drugs imported
- As par new standards and guidelines in place, each drug manufacturer has the chance to explore the market actively after registering their product under a specific law
- The authority performs on-site audits to make sure that drugs are manufactured and stored in compliance
- The audit helps in locating equipment flaws and assists in reducing risks that could one day harm a patient
- Maintaining compliance must therefore be a top priority for every manufacturer and distributor
DOCUMENT REQUIRED FOR CDSCO REGISTRATION
The Central drugs standard control organisation, which operates under Directorate general of health services, Ministry of Health & Family Welfare Government of India, requires the following documents for CDSCO Drugs Import License in India:
- Covering Letter
- Application Form, duly signed and sealed
- The Original power of attorney
- Product Label
- Manufacturing Licenses and Certification
- Challan of fees paid along with the application form
- Copy of import permission for new drugs
- Copy of a valid wholesale license
- Testing Report
- Specification of the cosmetic product
- Authorisation letter of the company
- Duly signed and sealed undertaking
- Notarised copy of Plant Master File
- Notarised copy of Drug Master File
- Original notarized copy of Manufacturing License, FSC, GMP, COPP ( For finished products)
- Attested copy of Product Registration Certificate (CFDA)from china or Certificate of suitability from (EDQM)
- Original label/specimen
FAQs FOR CDSCO REGISTRATION
Q1. What is a CDSCO certificate?
As per the Drugs and Cosmetics Act, 1940, CDSCO certificate is a mandatory requirement for the import of cosmetics into India.
Q2. Who regulates the import of cosmetics in India?
Import of cosmetics is regulated by CDSCO, full form, Central Drug Standard Control Organization through the DCGI, full form, Drugs Controller General of India.
Q3. Why is CDSCO important?
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Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring.
Q4. What products are regulated by CDSCO?
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In India, at present only notified medical devices are regulated as Drugs under the Drugs and Cosmetics Act 1940 and Rules made thereunder in 1945.
Q5. Who should register in CDSCO?
Authorized Signatory / Responsible person of the organization should fill the registration form. After submitting the Registration Form, Check Registered email for E-mail Verification. Submit ID proof, Undertaking, Address Proof Document in hard copy to CDSCO office.
Q6. Who is highest authority in CDSCO?
The Drug Controller General of India (DCGI) is the head of the Central Drugs Standard Control Organisation (CDSCO) in India.
Q7. What is CDSCO in quality assurance?
Central Drugs Standard Control Organization is committed to protect and promote public health in India. The employees of CDSCO discharge their duties with professional and scientific rigor, while ensuring safety, efficacy and quality of drugs, cosmetics and medical devices.
Q8. Q14. How to get a CDSCO license in India?
The process of CDSCO registration for the import of cosmetics involves the following steps:
- Gather the required documents.
- File and submit the CDSCO application at the SUGAM portal
- Wait for the CDSCO assessment
- CDSCO approves your application
- CDSCO grants the registration number for the import of cosmetics.
